House committee grills FDA over fungal meningitis outbreak

Nov 14, 2012 (CIDRAP News) – The first congressional hearing today on the fungal meningitis outbreak linked to tainted steroids was marked by tough questions for regulators, political wrangling, and an appearance by the owner of the compounding pharmacy that produced the drugs, but he declined to testify.

Members of the House Energy and Commerce Committee also heard poignant comments from Joyce Lovelace, the wife of one of the first patients who died in the outbreak and whose death helped alert health officials to problems with methylprednisolone acetate injections from New England Compounding Center (NECC).

So far 461 infections and 32 deaths from 19 states have been linked to the tainted steroids, which were used to treat back pain and joint problems, according to an update today from the Centers for Disease Control and Prevention (CDC). The total is 23 cases more than the last update on Nov 9. No new deaths were reported.

The fungal meningitis outbreak has spotlighted past problems at NECC and similar pharmacies and has drawn attention to a host of regulatory gaps affecting large compounding pharmacies that have evolved to resemble drug manufacturers. The Senate Health, Education, Labor, and Pension (HELP) Committee will hold a hearing on similar issues tomorrow.

Eddie Lovelace, a circuit court judge from Albany, Ky., died of a stroke on Sep 17 at age 78 after receiving three epidural injections—the last one on Aug 31— for back pain related to a March car accident. His wife told the committee that her husband walked 3 miles every morning and hoped to serve as a judge for 2 more years, then practice law alongside his granddaughter.

Eddie's first symptom was hand numbness after the second injection, which progressed to headaches and neuromotor problems, she recalled. "It was a nightmare to see someone perfectly healthy go quickly downhill."

As doctors at Vanderbilt University pieced together what caused Lovelace's death, his wife said she first heard about a possible link to contaminated steroids through media reports, followed by calls from the clinic that administered the injections.

In written testimony that she submitted along with her appearance before the committee, Lovelace urged members to put aside their partisan differences to pass laws to prevent another similar outbreak from contaminated compounding pharmacy drugs. "Don't just investigate. Instead, legislate and regulate," she wrote. "If you will do that, perhaps my family can take some solace in the fact that Eddie Lovelace's public service continues even after his death."

On Nov 6 the committee subpoenaed Barry Cadden, NECC's president and co-owner, to testify at the hearing. He took the stand flanked by his attorneys but refused to answer questions, citing his Fifth Amendment right to not testify. The chair of the Oversight and Investigations Subcommittee, Cliff Stearns, R-Fla., excused Cadden after he repeated the same response to several of the committee members.

The committee heard from and questioned two regulators, Margaret Hamburg, MD, commissioner of the US Food and Drug Administration (FDA), and Lauren Smith, MD, MPH, interim commissioner with the Massachusetts Department of Public Health. Hamburg is also scheduled to testify at tomorrow's Senate hearing.

Hamburg described a complex regulatory landscape that applies to large compounding pharmacies. She said federal laws exempt them from the same rules that cover drug manufacturers, and court decisions have muddled the authorities that the FDA does have over the pharmacies, leaving much of the regulatory work to states and opening up loopholes for an industry that has evolved from the image of the corner drugstore customizing ointments and treatments for individual patients.

Several of the committee members, however, pressed Hamburg for answers on why the FDA didn't do more to investigate and shut down NECC when problems surfaced about a decade ago. Members of both parties had tough questions for Hamburg, and some of the Republican members charged that the FDA already has the regulatory authority to oversee companies like NECC and questioned whether new laws were needed.

Smith told legislators that she was brought in by Massachusetts officials 3 weeks ago to lead the department through its investigation of and response to how its pharmacy boards handled problems at NECC over the past several years. She said the board's failure to take action contributed to the outbreak and that some staff who were involved in the decisions have been removed from their jobs. "We acknowledge the lapses," she said.

Some of the committee members complimented Smith for her comments taking responsibility, and charged Hamburg and the FDA with ducking the blame for the oversight lapses. Stearns said, "You're practicing plausible deniability."

Henry Waxman, D-Calif., pushed his colleagues to pass legislation to give the FDA more oversight of compounding pharmacies before the end of the year. "If there's an ambiguity, it's our job to clear it up," he said. Waxman also accused some Republican legislators of picking on Hamburg, because she is a member of President Obama's administration.

Edward Markey, D-Mass., whose office on Oct 29 issued a report detailing safety problems with products from compounding pharmacies over the past 10 years, said, "In that atmosphere of ambiguity, we have a mess on our hands." NECC, based in Framingham, is in Markey's House district.

Michael Burgess, MD, R-Tex., was among several on the committee who pushed Hamburg and the FDA to share more background e-mails and documents regarding events over the past year that touched on the agency's oversight of compounding pharmacies and earlier problems over the years with NECC.

Legislators said the documents are crucial for getting a clear picture of the oversight problems. "If we're going to craft legislation, how are we going to avoid making the same mistakes again?" he asked.

One subject that members of both parties agreed on was the value of small traditional compounders and that stricter oversight measures should avoid hurting their operations.

Hamburg said the FDA needs a tiered regulatory approach that holds nontraditional compounders that make high-risk products to the same standards as drug manufacturers, while allowing small, traditional pharmacies that make less-risky products to continue operating under a less restrictive framework.